The U.S. Food and Drug Administration (FDA) recently released draft guidance aimed at assisting manufacturers and processors of low-moisture, ready-to-eat (LMRTE) human foods in complying with the regulations outlined in 21 CFR part 117. This guidance is crucial for ensuring the safety and sanitation of a variety of LMRTE foods, including powdered infant formula, peanut butter, nut butters, powdered drink mixes, chocolate, medical foods, processed tree nuts, milk powders, powdered spices, snack foods, granola bars, and dry cereal.
The recommendations provided in this guidance are designed to help manufacturers and processors adhere to current good manufacturing practices (CGMPs), hazard analysis, and risk-based preventive controls, all of which are essential for maintaining a secure and hygienic food supply chain. By following the guidelines outlined in this document, companies can effectively prevent pathogen contamination events and implement corrective actions when necessary.
One of the key aspects addressed in this guidance is the establishment of a routine sanitation program for LMRTE foods. This program plays a critical role in preventing pathogen contamination and ensuring the overall safety of the food products. Additionally, the guidance offers recommendations for conducting root cause investigations following a contamination event, applying sanitizing treatments to mitigate contamination, identifying affected food, and emphasizing the limitations of relying solely on product testing for pathogen elimination.
While the guidance primarily focuses on environmental pathogens, the principles and recommendations outlined can also be applied to contamination events involving other types of pathogens. It is important to note that FDA guidance documents are not legally binding but rather serve as recommendations based on the agency’s current understanding of the subject matter. The use of the term “should” in these guidances indicates suggestions or recommendations, rather than mandatory requirements.
Interested parties have the opportunity to provide feedback on the draft guidance until May 7, allowing stakeholders to offer insights and perspectives that can further enhance the effectiveness and practicality of the recommendations put forth by the FDA. By engaging in this feedback process, manufacturers and processors can contribute to the development of guidelines that are both scientifically sound and operationally feasible within the food industry.
In conclusion, the FDA’s draft guidance for LMRTE foods is a valuable resource for companies involved in the manufacturing and processing of these products. By following the recommendations outlined in this document, businesses can strengthen their food safety practices, minimize the risk of pathogen contamination, and ultimately uphold the highest standards of quality and hygiene in the production of LMRTE foods.
